HHS · no agency ID · record R0875

ChatBot for Safety Reporting Portal Adverse Events and Product problems submissions

Department of Health and Human Services · HHS/FDA/ODT

Overview

Development stage: DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
High-impact designation: Not high-impactSource: c) Not high-impact
Impact justification: Not reported
Start date: 2024-03 (month precision)Source: Mar-24
Withheld from public reporting: NoSource: a) No

Mission

Topic area: Health and Medical
Operational functions: Chatbot or virtual assistant, Search and knowledge retrieval Derived by keyword rules; see methodology

Problem the AI is intended to solve

Increases data integrity and aid with routing the user to the correct commodity group to submit their adverse event or product problem. DRUID AI, a COTS tool, boasts a comprehensive suite of functionalities, encompassing conversational flows and seamless diverse data sources integrations such as SQL, ServiceNow, UiPath, API, and knowledge base services. Its sophisticated Natural Language Processing and Understanding capabilities empower precise interpretation of user queries across various languages and dialects.

Expected benefits

Increased user satisfaction by saving time providing faster form completion and less confusion on where to report their adverse event or product problem.

System outputs

The AI routes to the correct form and helps the user to complete the report faster and endures data integrity. The outputs uses knowledgebase to answer questions, format responses, routes to correct forms, and uses API to submit the report to SRP without having to use the existing legacy app.

Technology

AI classification: Natural language processingSource: Natural Language Processing: AI that processes, interprets, and shares information in human language.
System name(s): Safety Reporting Portal (SRP)
Custom-developed code: Yes
Public source code: No

Sourcing

How it was built: Contract and in-houseSource: c) Developed with both contracting and in-house resources
Vendor (as reported): Druid
Vendors (standardized): None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII: Yes
Privacy Impact Assessment: not publicly available
Authorization to Operate: Yes
Demographic features: k) None of the above
Training and evaluation data: Internal FDA structured and unstructured data from FDA.GOV web crawling
Federal Data Catalog: No

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Pre-deployment testingNo answer reported

AI impact assessmentNo answer reported

Independent reviewNo answer reported

Ongoing monitoringNo answer reported

Operator trainingNo answer reported

Fail-safeNo answer reported

Appeal processNo answer reported

User and public consultationNo answer reported

Potential impacts and how they were identified

Not reported